A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma.

Conditions

Severe asthma exacerbations in partial and uncontrolled preschool asthma

Brief summary

Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).

Detailed description

number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patients diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response, Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut, Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).

Related papers

No related papers found yet.

Interventions

DRUGTiotropium bromide monohydrate

DRUGRespimat® Inhaler one cartridge of Placebo

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).	—

Secondary

Measure	Time frame
number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patients diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response, Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut, Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).	—

Measure

Time frame

number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patients diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response, Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut, Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).

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Countries

Germany

Outcome results

None listed